ICH E6 (R2) – Miracle Pill For The Clinical R&D Industry
ACRP Clinical Researcher ICH E6 R2 – Miracle Pill for the Clinical R&D Industry Steve Young, Chief Operations Officer, CluePoints Publication of the long-awaited ICH E6 (R2) Guideline this year finally makes it official. A risk-based approach to clinical trial quality management – commonly referred to as risk-based monitoring or RBM – is now a […]
ICH E6 Rev 2 – Ask The Experts
Last week, we hosted our second webinar of 2017, Implementing Risk-Based Monitoring – What Does the ICH E6 Rev 2 Mean for My Company? There were many great questions from the attendees. In fact, we had so many questions that we couldn’t get through them all! So as promised, we’ve documented the most common questions, along with […]
Webinar Recording: What Does ICH E6 R2 Mean For Me And My Company?
This week, CluePoints hosted a webinar with Paragon Solutions, which was geared towards preparing attendees on how to take advantage of the ICH E6 revisions to ensure appropriate consideration of risk in study design and management. Attendees learned about the key ICH E6 updates related to Risk-Based Monitoring and their purpose, how Central Statistical Monitoring and Key […]
6th Annual CROWN Congress: Sessions You Can’t Afford To Miss + 15% Discount Code
It’s really no secret that the evolving regulatory landscape for clinical trials is a hot topic amongst the community. Just take a look at the agenda for the 6thAnnual CROWN Congress, it’s jam-packed with sessions focused on the eagerly anticipated ICH E6 revisions, the new EU 536/2014 clinical trial regulations, risk management and centralized monitoring. Of […]
Six Ways To Get The Most Out Of Outsourcing In Clinical Trials West Coast ‘17
There’s only a couple of weeks to go until Arena’s flagship event, Outsourcing in Clinical Trials West Coast returns to Burlingame. The must-attend event brings together over 700 clinical professionals from the Bay Area and beyond, to discuss clinical outsourcing strategies and overcome key challenges within clinical operations. From sessions to booth activities to after-hours […]
The FDA Is Knocking At Your Door – Are You Ready For An FDA Site Inspection?
Are you ready for an FDA site inspection? You may have heard that CluePoints signed an agreement with the FDA. This Cooperative Research and Development Agreement(CRADA) explores a data-driven approach to selecting sites which exhibit data anomalies indicative of fraud, misconduct or sloppiness. This shouldn’t come as a shock, since The FDA has been very vocal […]
Webinar: Risk-Based Monitoring Implementation – What Does ICH E6 Rev2 Mean For My Company?
With the official publication of the long awaited revision of the ICH E6 Guidelines, now is the time to take advantage of the new information to ensure appropriate consideration of risk in study design and management. For this webinar, CluePoints is again teaming up with Paragon Solutions, to highlight the key changes in the mandate and explain how […]
CluePoints Answers Your Risk-Based Monitoring Implementation Questions
Q1) Are the indicators percentages? E.g., % AEs for the site v study or just number (which could indicate that there are many AEs as there are many subjects) The units for each KRI may be different. In the example of AE Rate, we suggest computing a rate of AE’s per patient visit. So you […]
Risk-Based Monitoring Insights From The Industry: Angie Maurer
Part Seven In the latest of our eight-part ‘Insights from the Industry’ series, we caught up with Angie Maurer, Co-Founder & CEO at Zynapsys. Here’s what she had to share with us. When it comes to the practical implementation of Risk-Based Monitoring, where do you observe differences in current best Risk-Based Monitoring practices between companies and […]
Risk-Based Monitoring Insights From The Industry: Jamie O’Keefe
Part Six In the latest of our eight-part Q&A series, we catch up with Jamie O’Keefe, Vice President, Life Sciences, and R&D Practice at Paragon Solutions to get his thoughts on the latest issues in Risk-Based Monitoring (RBM). When it comes to the practical implementation of Risk-Based Monitoring, where do you observe differences in current best Risk-Based Monitoring […]
